Blog
RSS FeedPosted by Michael Wonder on 20 Mar 2018
FDA, industry ponder changes to clinical trials for rare disease treatments
19 March 2018 - FDA statisticians pondered changing how the agency uses statistics to approve drugs for rare disease at ...
Posted by Michael Wonder on 28 Feb 2018
Europe follows FDA with plans to help early Alzheimer's drugs
28 February 2018 - European regulators are following in the footsteps of the U.S. Food and Drug Administration with plans ...
Posted by Michael Wonder on 21 Feb 2018
Mandatory requirements for an effective application
21 February 2018 - Applicable for applications lodged from 9 February 2018. ...
Posted by Michael Wonder on 19 Feb 2018
RMAT vs. breakthrough vs. fast track: companies seek clarity on FDA draft guidance
19 February 2018 - Industry groups BIO, the Alliance for Regenerative Medicine and the International Society for Cellular Therapy, as well ...
Posted by Michael Wonder on 16 Feb 2018
FDA opens new path for Alzheimer's treatments
16 February 2018 - Draft guidance comes after Merck failure, years of others. ...
Posted by Michael Wonder on 03 Feb 2018
Strengthened guidance on follow-up and risk management for ATMP developers
2 February 2018 - Guideline to streamline procedures and better address the specific requirements of ATMP developers published for consultation ...
Posted by Michael Wonder on 11 Jan 2018
New guidance: When can the FDA refuse to file NDAs and BLAs?
10 January 2018 - According to US FDA regulations, the regulatory agency may refuse to file a new drug application ...
Posted by Michael Wonder on 19 Dec 2017
Guidelines for statistical analysis plans
19 December 2017 - The emergence of the randomised clinical trial as the gold standard for the evaluation of new clinical ...
Posted by Michael Wonder on 30 Nov 2017
Advancing medicinal nicotine replacement therapies as new drugs – a new step in FDA’s comprehensive approach to tobacco and nicotine
29 November 2017 - As the leading cause of preventable disease and death in the United States, tobacco causes more than ...
Posted by Michael Wonder on 28 Nov 2017
FDA issues guidance that could make it easier for EpiPen rivals to come to market
28 November 2017 - FDA issued guidance that says generic copies with some design differences may be approved as substitutable products. ...
Posted by Michael Wonder on 28 Nov 2017
Guidance to help pharma companies prepare for Brexit
28 November 2017 - Additional guidance relates to medicines for human and veterinary use. ...
Posted by Michael Wonder on 17 Nov 2017
Towards a single development programme for new antibiotics in EU, Japan and US
17 November 2017 - EMA, PMDA and FDA to further align data requirements and explore options to streamline paediatric development. ...
Posted by Michael Wonder on 16 Nov 2017
FDA announces comprehensive regenerative medicine policy framework
16 November 2017 - Framework aims to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy. ...
Posted by Michael Wonder on 21 Oct 2017
FDA releases flurry of new, revised drug-specific guidance documents
19 October 2017 - The US FDA on Thursday released new draft guidances for 32 drugs, including for those companies ...
Posted by Michael Wonder on 02 Oct 2017
Statement from FDA Commissioner Scott Gottlieb on the FDA’s adverse event reporting system and new search tool
2 October 2017 - The FDA’s adverse event reporting system is a database that contains adverse event reports, medication error reports ...